On March 29, 2022 BioCurity is a private preclinical biotech company developing supportive cancer oncology drugs to prevent or mitigate some of the side effects of radiation therapy for cancer patients (Press release, BioCurity Pharmaceuticals, MAR 29, 2022, View Source [SID1234611140]). BioCurity reported the Company received a notice of allowance of claims from the United States Patent and Trademark Office for the Company’s United States patent that covers the use of the Company’s cerium oxide nanoparticles for the reduction of side effects caused by radiation therapy for lung and pancreatic cancer patients receiving a combination of radiation therapy and chemotherapy as part of their treatment regimen .

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This new patent builds upon the 8 US patents BioCurity exclusively controls related to its novel drug development. BioCurity also exclusively controls its international patents, which currently exist in Australia, China, Europe, Hong Kong, Japan, and Mexico, and cover the use of the Company’s cerium oxide nanoparticle technology for patients with certain cancers treated with radiation combined with chemotherapy.

Globally, it is estimated that 6 million of the 18 million annually diagnosed new cancer patients receive radiation. The short and long-term side effects of radiation therapy to various organs and tissues in humans have been well characterized, can impair a cancer patient’s medical treatment plan, and can leave cancer survivors with permanent adverse conditions. Treatment of these side effects cost more than 3 billion dollars annually in the US. The global cancer supportive care market is projected to reach approximately 41 billion dollars by 2027 and is driven by the growing prevalence of cancer.

"BioCurity’s scientific discovery in an IV formulation for internal tissue as well as a topical formulation to protect against skin damage offers the potential to prevent the often-devastating side effects associated with radiation therapy and to enhance the treatment outcomes for patients undergoing radiation therapy alone or in combination with chemotherapy to treat their cancer. Each of the formulations have been studied in various proof of concept animal models of head and neck, lung, breast, pancreatic, colorectal, and prostate cancer. The positive preclinical data in these animal models suggest the potential use in multiple types of cancers where radiation therapy is used alone or in conjunction with chemotherapy to treat cancer patients," said Dr. Cheryl Baker PhD, Scientific Co-Founder, and a Board member of BioCurity.

BioCurity’s clinical development team led by CSSi LifeSciences has an excellent track record in working with small and emerging biopharmaceutical companies to advance their lead drug products to and through commercialization. With 100% success in obtaining an Investigational New Drug and 500 successful drugs, diagnostics and devices commercialized.

On March 29, 2022 Cytonus Therapeutics Inc. (Cytonus), a biotechnology company developing therapeutic products for targeted delivery in vivo, reported that their CSO, Dr. Richard Klemke Ph.D., will present the preclinical progress made on Cytonus’ lead Cargocyte product candidates at the annual AACR (Free AACR Whitepaper) meeting in New Orleans (Press release, Cytonus Therapeutics, MAR 29, 2022, View Source [SID1234611139]).

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Cargocytes armed with interleukin 12 (CA-IL-12) can be engineered to actively home, migrate, and penetrate deep into specific disease foci and synthesize biologically active therapeutic within the target tissues, hours after intravenous administration.

Dr. Klemke will share data demonstrating striking infiltration of engineered Cargocytes into solid tumors in in vivo models of metastatic Triple Negative Breast Cancer (TNBC), localizing and synthesizing the company’s proprietary Interleukin twelve (IL-12) construct. Furthermore, Dr. Klemke will share in vivo data demonstrating the efficacy of tumor-localized activity of CA-IL-12 in reducing tumor burden, particularly in combination with immune checkpoint inhibitors.

Abstract #3519: Bioengineering enucleated cell vehicles for targeted delivery of Interleukin 12 to metastatic tumors.

These results highlight the capabilities of Cytonus’ innovative Cargocyte platform in addressing solid tumor penetration challenges. Importantly, Cargocytes offer localized delivery of potent immunotherapies in a controlled manner to enhance their safety profile.

"While immunocytokine therapeutics can modulate the immune system, systemic delivery often results in adverse events and toxicity which limits their clinical utility. What is remarkable about our data is that we demonstrate a historically toxic cytokine (IL-12) can be localized to metastatic sites with exquisite accuracy and without systemic off-target effects. Our unique approach leads to a substantial reduction in metastatic burden and as such has potential to treat patients with late-stage cancers," said Dr. Remo Moomiaie-Qajar, M.D. co-founder and CEO of Cytonus Therapeutics.

"Arguably the most exciting discovery in immune oncology in the past decade has been the development of immune checkpoint inhibitors (ICI). Unfortunately, only 13% of all patients respond to ICI therapy. Our data clearly demonstrates the ability of CA-IL-12 to make recalcitrant tumors (TNBC) responsive to ICI therapy. These promising findings demonstrates the enabling nature of CA-IL-12 to expand the utility of ICI to the large number of cancer patients normally refractory to this approach," said Dr. Moomiaie-Qajar, M.D.

About Cargocyte

Cargocyte products are derived from enucleated cell lines and are uniquely engineered with specific disease targeting molecules to safely transport therapeutic payloads intravenously and deep into difficult-to-reach target tissues. Cargocytes can deliver and actively produce the therapeutic agent of choice on-site in a controlled, predictable, and safe manner. The proprietary Cargocyte technology is a first-in-class therapeutic platform with numerous potential medical applications across unmet therapeutic areas. Cytonus is developing a broad and deep pipeline of bioengineered Cargocytes for targeted delivery of a wide range of therapeutic modalities including Protein, Peptides, RNAs, ASOs, small molecule drugs, viruses, and gene editing agents.

On March 29, 2022 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported that Kinnari Patel, Pharm.D., MBA, President and Chief Operating Officer, will deliver a virtual company presentation at the Guggenheim 3rd Annual Genomic Medicines and Rare Disease Conference on Friday, April 1 at 8:00 a.m. ET. Gaurav Shah, M.D., Chief Executive Officer, will present at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11 at 10:15 a.m. ET (Press release, Rocket Pharmaceuticals, MAR 29, 2022, View Source [SID1234611138]).

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A live audio webcast of the presentations will be available under "Events" in the Investors section of the Company’s website at View Source The webcast replay will be available on the Rocket website following the conferences.

On March 29, 2022 Thermo Fisher Scientific reported that launched the CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform that delivers results in as little as a single day (Press release, Thermo Fisher Scientific, MAR 29, 2022, View Source [SID1234611136]). Designed for use in clinical laboratories, the fully validated system enables users to perform both diagnostic testing and clinical research on a single instrument.

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"With faster answers, the results can aid clinicians in their patient management decision making which may include therapeutic options."

"Next-generation sequencing has become an essential tool to bring the promise of precision medicine therapies to patients. With the automated, easy-to-use Genexus Dx Integrated Sequencer, any hospital – including regional and community hospitals – can bring NGS in-house, giving clinicians access to timely, comprehensive genomic profiling results," said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "With faster answers, the results can aid clinicians in their patient management decision making which may include therapeutic options."

In support of increasing physicians’ access to rapid NGS results, Thermo Fisher is also developing a complete sample-to-report diagnostic workflow and a portfolio of clinically validated assays, including those for comprehensive genomic profiling and hemato-oncology, on the Genexus System.

Thermo Fisher introduced the Ion Torrent Genexus System for research use only in 2019 as the first fully integrated NGS platform that delivers results in as little as 24 hours. The platform’s automated workflow minimizes user intervention and the potential for human error, making NGS accessible for all labs.

For more information on the Ion Torrent Genexus Dx Integrated Sequencer, please visit thermofisher.com/genexusDx.

On March 29, 2022 Australian biotech company Noxopharm (ASX:NOX) reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Veyonda, its lead oncology drug candidate, for use in the treatment of soft tissue sarcoma (Press release, Noxopharm, MAR 29, 2022, View Source [SID1234611135]).

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The ODD program was established by the FDA to encourage development of safe and effective treatments of rare diseases and disorders that affect fewer than 200,000 people in the U.S. annually. Soft tissue sarcomas are rare but often fatal cancers — up to 50% of high-grade sarcoma patients develop metastases and die within 12 months.

"Only four of approximately 360 approved ODDs last year went to Australian companies, which demonstrates the high bar that is being set by the FDA," said Noxopharm CEO and Managing Director Gisela Mautner, M.D.-Ph.D., MPH. "It is pleasing that the Noxopharm application for Orphan Drug Designation was approved so quickly."

Noxopharm recently began its Phase 1 CEP-2 trial at City of Hope in Los Angeles for Veyonda, in combination with the chemotherapy drug doxorubicin, for first-line treatment of soft tissue sarcoma.

The ODD program provides a number of significant benefits, including:

A seven-year period of market exclusivity — the FDA will not approve a subsequent drug for the same use within this timeframe
Waiver of new drug application fees, valued at approximately $2.9 million in 2021
Opportunities for grant funding from the Office of Orphan Products Development
Regulatory guidance and assistance from the FDA for the drug development process
"This designation will allow us to lower current development costs and provide a future competitive and financial advantage of Veyonda," Dr. Mautner said. "With the ODD now secured, my team will be able to focus on moving our preclinical assets along the drug development process, while continuing to deliver on our clinical program plan."